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BACKGROUND INFORMATION ON THE PROCEDURE 1. Submission of the dossier The applicant SmithKline Beecham Biologicals S.A., Belgium, submitted on 28 June 1999 to the European Agency for the Evaluation of Medicinal Products (EMEA), an application to obtain a marketing authorisation in accordance with the Centralised Procedure for the medicinal product Infanrix penta (combined Diphtheria, Tetanus, acellular Pertussis, Hepatitis B recombinant and inactivated Poliomyelitis vaccine) falling within the scope of Part A of the Annex to Council Regulation No (EC) 2309/93. The Rapporteur and Co-Rapporteur appointed by the CPMP were: Rapporteur: Dr. Pieter Neels Co-Rapporteur: Dr. Manfred Haase Licensing status: The product was not licensed in any country inside or outside the EU at the time of submission of the application. 2. Steps taken for the assessment of the product • The procedure started on 30 July 1999. • The Rapporteur’s first assessment report was circulated to all members of the CPMP on

11 October 1999. • The Co-Rapporteur’s first assessment report was circulated to all members of the CPMP on

6 October 1999. • In its meeting on 9-10 November 1999, the Biotechnology Working Party (BWP) discussed the

draft list of questions on Part II of the dossier and endorsed the (Co)-Rapporteurs’ recommendation to the CPMP. A BWP report was prepared for adoption at the CPMP meeting on 16-18 November 1999.

• During its meeting on 16-18 November 1999, the CPMP agreed on the consolidated list of

questions to be sent to the applicant on 18 November 1999. • The applicant submitted the responses to the consolidated list of questions on

23 December 1999. • The Rapporteur and the Co-Rapporteur circulated the joint response assessment report on the

applicant’s responses to the consolidated list of questions to all CPMP members on 22 February 2000.

• During its meeting on 7-8 March 2000, the Biotechnology Working Party (BWP) discussed the

draft list of outstanding issues on Part II of the dossier and endorsed the (Co)-Rapporteur’s recommendation to the CPMP. A BWP report was prepared for adoption at the CPMP meeting on 14-16 March 2000.

• During its meeting on 14-16 March 2000, the CPMP agreed on a list of outstanding issues to be

addressed by the company in writing (quality and safety issues) and during an oral explanation (safety issues) held on 24 May 2000.

• The applicant submitted the written responses to the outstanding issues on 3 May 2000. • The Rapporteur circulated a further assessment report, taking into account the company’s

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responses on the outstanding quality and safety issues, to all CPMP members on 12 May 2000. • An ad hoc expert group meeting on clinical issues was held on 22 May 2000 and a report from

this meeting was circulated to all CPMP members on 23 May 2000. • The applicant submitted updated information relating to Part II.V of the dossier to all CPMP

Members on 15 June 2000. • The Rapporteur’s assessment report on the supplementary information relating to Part II.V was

circulated on 15 June 2000. • During its meeting on 20-21 June 2000, the Biotechnology Working Party (BWP) discussed the

Rapporteur’s assessment report on the supplementary information relating to Part II.V of the dossier and endorsed a recommendation to the CPMP. A BWP report was prepared for adoption at the CPMP meeting on 27-29 June 2000.

• During the meeting on 27-29 June 2000, the CPMP, in the light of the overall data submitted

and the scientific discussion within the Committee, issued a positive opinion for granting a Marketing Authorisation for Infanrix penta on 29 June 2000. The applicant agreed to submit additional information regarding quality/clinical/safety data within the defined timeframe.